Long-term treatment with teduglutide: a 48-week open-label single-center clinical trial in children with short bowel syndrome

Short bowel syndrome (SBS) is the main cause of intestinal failure in children. This single-center study evaluated the safety and efficacy of teduglutide in pediatric patients with SBS–associated intestinal failure (SBS-IF). Children with SBS followed at our center with ≥2 y on parenteral nutrition...

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Published in:The American journal of clinical nutrition 2023-06, Vol.117 (6), p.1152-1163
Main Authors: Lambe, Cécile, Talbotec, Cécile, Kapel, Nathalie, Barbot-Trystram, Laurence, Brabant, Séverine, Abi Nader, Elie, Pigneur, Bénédicte, Payen, Elise, Goulet, Olivier
Format: Article
Language:English
Subjects:
Absorption
Calories
Child
Children
Citrulline
Clinical trials
Energy absorption
Energy intake
Gastrointestinal Agents - adverse effects
GLP-2 analog
Health services
home parenteral nutrition
Humans
Intestinal absorption
Intestinal Failure
Intestine
Intestine, Small
Parenteral nutrition
parenteral nutrition dependency index
Pediatrics
Peptides - therapeutic use
Safety
Short bowel syndrome
Short Bowel Syndrome - therapy
Small intestine
stool balance analysis
teduglutide
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Summary:Short bowel syndrome (SBS) is the main cause of intestinal failure in children. This single-center study evaluated the safety and efficacy of teduglutide in pediatric patients with SBS–associated intestinal failure (SBS-IF). Children with SBS followed at our center with ≥2 y on parenteral nutrition (PN) and with small bowel length 20% of PN requirements with a median PNDI = 50% (IQR: 38–81), (PN intake: 23.5 calories/kg/d IQR: 14.6–26.2), P < 0.01. At week 48, 8 children (32%) were weaned completely off PN. Plasma citrulline increased from 14 μmol/L (IQR: 8–21) at baseline to 29 μmol/L (IQR: 17–54) at week 48 (P < 0.001). Weight, height, and BMI z-scores remained stable. The median total energy absorption rate increased from 59% (IQR: 46–76) at baseline to 73% (IQR: 58–81) at week 48 (P = 0.0222). Fasting and postprandial endogenous GLP-2 concentrations increased at weeks 24 and 48 compared with baseline. Mild abdominal pain at the early phase of treatment, stoma changes, and redness at the injection site were commonly reported. Increased intestinal absorption and PN dependency reduction were observed with teduglutide treatment in children with SBS-IF. ClinicalTrials.gov NCT03562130. https://clinicaltrials.gov/ct2/show/NCT03562130?term=NCT03562130&draw=2&rank=1
ISSN:0002-9165
1938-3207
DOI:10.1016/j.ajcnut.2023.02.019